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Capsaicinoid Ingestion, Human Metabolism and Exercise (Phase 1)

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ClinicalTrials.gov Identifier: NCT02139852
Recruitment Status : Unknown
Verified September 2015 by Dr. Jamie Burr, University of Prince Edward Island.
Recruitment status was:  Active, not recruiting
First Posted : May 15, 2014
Last Update Posted : September 17, 2015
Sponsor:
Collaborator:
OmniActive Health Technologies
Information provided by (Responsible Party):
Dr. Jamie Burr, University of Prince Edward Island

Tracking Information
First Submitted Date  ICMJE May 6, 2014
First Posted Date  ICMJE May 15, 2014
Last Update Posted Date September 17, 2015
Study Start Date  ICMJE June 2014
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2014)
Energy substrate use (Fat vs Carbohydrate contributions to metabolism) [ Time Frame: 10 weeks ]
Expired gas analysis using a metabolic computer to calculate respiratory exchange rates.
Original Primary Outcome Measures  ICMJE
 (submitted: May 13, 2014)
Energy substrate use (Fat vs Carbohydrate contributions to metabolism) [ Time Frame: 12 weeks ]
Expired gas analysis using a metabolic computer to calculate respiratory exchange rates.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2014)
Cardiovascular risk factors [ Time Frame: 10 weeks ]
Vascular reactivity- endothelial function (Endopat), vascular stiffness (Pulse wave velocity), HRV (heart rate variability), Blood lipid/Glucose panel, blood pressure
Original Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2014)
Cardiovascular risk factors [ Time Frame: 12 weeks ]
Vascular reactivity- endothelial function (Endopat), vascular stiffness (Pulse wave velocity), HRV (heart rate variability), Blood lipid/Glucose panel, blood pressure
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Capsaicinoid Ingestion, Human Metabolism and Exercise
Official Title  ICMJE The Physiological Effects of Capsaicinoid Ingestion on Human Metabolism and Exercise Performance
Brief Summary

Capsaicinoids (the active ingredient in hot peppers) have been shown to cause a moderate increase in energy expenditure (50 kcal/day) as well as reductions in appetite, energy intake, and (visceral) adiposity. As such, there is considerable interest in capsaicinoid for weight loss supplements. Of particular interest are the recent findings that free-fatty acids in the blood are elevated 2-2.5hrs post ingestion, yet changes in typical cardiovascular or sympathetic nervous tone indicators (heart rate, blood pressure) were unaffected, suggesting some of the negative consequences of other stimulants may be avoided. At present, however, more in depth investigations of the effects on endothelial function, vascular autonomic tone and inflammation are lacking.

The investigators seek to understand the effect of 3 months capsaicinoid ingestion on alterations in body composition, traditional cardiovascular risk factors and cardiovascular function

Hypotheses:

1) Continued use of capsaicinoids will alter resting metabolism substrate use, which will result in moderate (but clinically meaningful) alterations in body composition manifested as a decrease in adiposity. 2) Blood lipids will be unaffected by capsaicinoid use, as will brachial blood pressure. 3) Levels of systemic inflammation may increase slightly, and this could have an effect on vascular reactivity to hyperemic flow or baseline vascular tone. However, previous research suggests that these alterations will not be manifested in autonomic nervous tone assessed by changes in heart rate variability.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Metabolism
Intervention  ICMJE Dietary Supplement: Capsaicin
Study Arms  ICMJE
  • Experimental: capsaicin
    Capsaicin
    Intervention: Dietary Supplement: Capsaicin
  • Placebo Comparator: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 13, 2014)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2016
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects will be male or female
  • 18 yr -45yr and free from any known or suspected chronic conditions.
  • General health and suitability to participate in an exercise/health research study will be confirmed through use of the PAR-Q+ screening questionnaire

Exclusion Criteria:

  • Any participant who has a positive answer to a screening question will be required to seek physician approval prior to any physical exercise.
  • Baseline arrhythmia (tachycardia (>100pbm) and systolic or diastolic hypertension (>140/90 mmHg) will also be reason for exclusion.
  • During baseline anthropometric assessment we will confirm that participants all fall within a typical BMI range (20-30 kg/m2) of either "normal" weight or "overweight", but not "underweight" or "obese".
  • Persons who take cardiovascular medications, metabolic medications, smoke cigarettes, excessively consume alcohol, are prone to heartburn, or have a previous diagnosis of hyperlipidemia or hyperinsulemia will also be excluded
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02139852
Other Study ID Numbers  ICMJE OAHTCAPX-003-2014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Jamie Burr, University of Prince Edward Island
Study Sponsor  ICMJE University of Prince Edward Island
Collaborators  ICMJE OmniActive Health Technologies
Investigators  ICMJE Not Provided
PRS Account University of Prince Edward Island
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP